Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MK-1029 in Participants With Mild to Moderate Asthma

NCT ID: NCT01370317

Last Updated: 2019-01-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-01
• Study Completion Date: 2011-12-27

Brief Summary

This study will evaluate the safety, tolerability, and pharmacokinetics (PK) of multiple dose treatment with MK-1029 in adults with mild to moderate persistent asthma.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MK-1029

Group Type: EXPERIMENTAL

MK-1029

Intervention Type: DRUG

Five (5) X 100 mg capsules, orally, once daily for 28 days

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo for MK-1029

Intervention Type: DRUG

Five (5) X 100 mg capsules, orally, once daily for 28 days

Interventions

MK-1029

Five (5) X 100 mg capsules, orally, once daily for 28 days

Intervention Type: DRUG

Placebo for MK-1029

Five (5) X 100 mg capsules, orally, once daily for 28 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• If female, must be of non-childbearing potential
• Have a history of mild to moderate asthma for at least 6 months
• Other than asthma, in general good health
• Able to perform reproducible pulmonary function testing
• Is a nonsmoker and/or has not used nicotine or nicotine-containing products for at least 12 months
• Have body mass index (BMI) ≥17 kg/m^2, but ≤35 kg/m^2

Exclusion Criteria

• Demonstrate a decrease in absolute forced expiratory volume in 1 second (FEV1) of >20% from the Screening Visit to the Baseline Visit
• Experience a decrease in AM or PM peak expiratory flow (PEF) below the Stability Limit on any 2 consecutive days prior to the Baseline Visit
• Require the use of >8 inhalations per day of short-acting beta2-agonist metered dose inhaler (MDI) or >2 nebulized treatments per day of 2.5 mg albuterol, on any 2 consecutive days from the Screening Visit up to the Baseline Visit
• Experience an exacerbation defined as a clinical deterioration of asthma, as judged by the clinical investigator, that results in emergency treatment, hospitalization due to asthma, or treatment with additional, excluded medication (other than short-acting beta agonists [SABA]) at any time from the Screening Visit up to the Baseline Visit
• Have been hospitalized for treatment of asthma or required oral corticosteroids for treatment of asthma within the past 6 months, or has ever required ventilator support for respiratory failure secondary to asthma
• Require the chronic use of high-dose inhaled corticosteroids
• Have been diagnosed with chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease, other than asthma
• Have a history of any illness that might confound the results of the study or poses additional risk to the participant
• Have had recent (within 4 weeks of first dose) or ongoing upper or lower respiratory tract infection
• Is nursing
• Have a history of significant multiple and/or severe allergies (including latex allergy), or has had an anaphylactic reaction or significant intolerability to prescription or non-prescription drugs or food

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

Call for Information

Costa Mesa, California, United States

Call for Information

Rolling Hills Estates, California, United States

Merck Sharp & Dohme

North Ryde, , Australia

Merck Sharp & Dohme (New Zealand) Ltd.,

Wellington, , New Zealand

MSD (Pty) LTD South Africa

Midrand, , South Africa

Countries

United States; Australia; New Zealand; South Africa

Other Identifiers

MK-1029-006

Identifier Type: OTHER

Identifier Source: secondary_id

1029-006

Identifier Type: -

Identifier Source: org_study_id